Persistent secretory otitis media, severe symptoms of ETD or baro-challenged ETD Ear, Nose and Throat Nonsuppurative otitis media, unspecified
Conditions
Interventions
Parallel-group randomisation is made after local anaesthesia induction before the operation. Patients are treated with either BET or sham surgery under local anaesthesia. The patients are blinded to t
Sponsors
Helsinki University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients in this study suffer from dilatory Eustachian tube dysfunction and are deemed suitable for BET. Possible indications are: 1. Persistent secretory otitis media 2. Severe symptoms of ETD 3. Baro-challenged ETD
Exclusion criteria
Exclusion criteria: 1. The occurrence of cleft palate in any form 2. Current ventilating grommet 3. Tympanic membrane perforation 4. Adhesive otitis 5. Cholesteatoma 6. Cystic fibrosis 7. Immotile cilia syndrome 8. Untreated nasal polyposis 9. Samter's triade 10. Untreated gastroesophageal reflux disease 11. Other mechanical obstruction in nasopharynx
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline, 3 months and 1 year: 1. Valsalva maneuver based on physicians descriptive findings 2. Otomicroscopy based on physicians descriptive findings 3. Tympanometry results classified as A, B and C type outcomes 4. Tubomanometry results based on the Eustachian tube opening and opening latency index 5. Need for grommets | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life measured with disease specific questionnaire ETDQ7 at baseline, 3 months and 1 year | — |
Countries
Finland
Outcome results
None listed